La. Admin. Code tit. 33 § XV-304

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-304 - Radioactive Material Other Than Source Material

A. Exempt Concentrations

1. Except as provided in Paragraphs A.3 and 4 of this Section, any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in schedule A of this Chapter.

2. This Section shall not be deemed to authorize the import of byproduct material or products containing byproduct material.

3. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in these regulations to the extent that this person transfers byproduct material contained in a product or material in concentrations not in excess of those specified in schedule A of this Chapter and introduced into the product or material by a licensee holding a specific license issued pursuant to 10 CFR 32.11 expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

4. No person may introduce byproduct material into a product or material, knowing or having reason to believe that it will be transferred to persons exempt under LAC 33:XV.304.A.l or equivalent regulations of any agreement state, except in accordance with a specific license issued pursuant to 10CFR32 .il.

B. Exempt Quantities

1. Except as provided in Paragraphs B.3-5 of this Section, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities, none of which exceeds the applicable quantity set forth in schedule B of this Chapter.

2. Any person who possesses byproduct material received or acquired before September 25, 1971, under the general license, formerly provided in Section B.22, or under a similar general license is exempt from the requirements for a license set forth in this Chapter to the extent that such person possesses, uses, transfers, or owns such byproduct material. This exemption does not apply for radium-226.

3. LAC 33:XV.304.B does not authorize the production, packaging, repackaging, or transfer of byproduct material for purposes of commercial distribution or the incorporation of byproduct material into products intended for commercial distribution.

4. No person may, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in schedule B of this Chapter knowing, or having reason to believe, that such quantities of byproduct material will be transferred to persons exempt under Subsection B of this Section or equivalent regulations of the U.S. Nuclear Regulatory Commission or any other agreement state, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 32.18 or by the administrative authority in accordance with LAC 33:XV.328.B, which license states that the byproduct material may be transferred by the licensee to persons exempt under Subsection B of this Section or the equivalent regulations of the U.S. Nuclear Regulatory Commission, or any other agreement state or licensing state. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

5. No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in 10 CFR 30.71 schedule B, except for byproduct material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this Chapter.

C. Exempt Items

1. Certain Items Containing Byproduct Material. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. Except for persons who apply byproduct material to, or persons who incorporate byproduct material into, the following products, or persons who initially transfer for sale or distribution the following products containing byproduct material, any person is exempt from these regulations to the extent that he or she receives, possesses, uses, transfers, owns, or acquires the following products:

a. timepieces or hands or dials containing not more than the following specified quantities of byproduct material and not exceeding the following specified levels of radiation:

i. 25 millicuries (925 MBq) of tritium per timepiece;

ii. 5 millicuries (185 MBq) of tritium per hand;

iii. 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial);

iv. 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece;

v. 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand;

vi. 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial);

vii. the levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(a). for wrist watches, 0.1 millirad (1 µGy) per hour at 10 centimeters from any surface;

(b). for pocket watches, 0.1 millirad (1 µGy) per hour at 1 centimeter from any surface; and

(c). for any other timepiece, 0.2 millirad (2 µGy) per hour at 10 centimeters from any surface;

viii. 1 microcurie (0.037 MBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007;

b. devices such as:

i. static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 500 microcurie (18.5 MBq) of polonium-210 per device;

ii. ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 (µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device;

iii. such devices authorized before October 23, 2012, for use under the general license then provided in 10 CFR 31.3 and equivalent regulations of agreement states and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Nuclear Regulatory Commission;

c. precision balances containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part manufactured before December 17, 2007.

d. marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas manufactured before December 17, 2007;

e. ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires;

f. electron tubes, provided that no tube contains more than one of the following specified quantities of byproduct material:

i. 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

ii. 1 microcurie of cobalt-60;

iii. 5 microcuries of nickel-63;

iv. 30 microcuries of krypton-85;

v. 5 microcuries of cesium-137;

vi. 30 microcuries of promethium-147; and

vii. provided further, that the levels of radiation from each electron tube containing byproduct material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber; and

viii. for purposes of this Subsection, electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents;

g. ionizing radiation measuring instruments containing, for the purposes of internal calibration or standardization, one or more sources of byproduct material, provided that:

i. each source contains no more than one exempt quantity set forth in Schedule B of this Chapter;

ii. each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Schedule B of this Chapter, provided that the sum of such fractions shall not exceed unity; and

iii. for purposes of this Section, 0.05 microcurie of americium-241 is considered an exempt quantity under Schedule B of this Chapter.

2. Self-Luminous Products Containing Byproduct Material

a. Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from the requirements for a license set forth in these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR 32.22, which license authorizes the initial transfer of the product for use under this Subparagraph. Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under this Subparagraph, shall apply for a license under 10 CFR 32.22 and for a certificate of registration in accordance with 10 CFR 32.210. The exemption in this Subparagraph does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

b. Radium-226. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie of radium-226 that were acquired prior to April 20, 1977.

3. Gas and Aerosol Detectors Containing Byproduct Material

a. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing byproduct material, any person is exempt from the requirements for a license in these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in gas and aerosol detectors designed to protect health, safely, or property and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.26, which license authorizes the initial transfer of the product for use under this Section. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a state under comparable provisions to 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

b. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use under LAC 33:XV.304.C.3.a shall apply for a license under 10 CFR 32.26 and for a certificate of registration in accordance with 10 CFR 32.210.

c. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a licensing state shall be considered exempt under LAC 33:XV.304.C.3.a, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that the device meets the requirements of LAC 33:XV.328.C.

4. Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic Use for Humans

a. Except as provided in Subparagraphs C.4.b and c of this Section, any person is exempt from the requirements for a license set forth in these regulations provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1µCi) carbon-14 urea each (allowing for nominal variation that may occur during the manufacturing process), for "in vivo" diagnostic use for humans.

b. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license in accordance with LAC 33:XV. Chapters 3 and 7.

c. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license in accordance with LAC 33:XV.328.K.

d. Nothing in this Section relieves persons from complying with applicable FDA, other federal, and state requirements governing receipt, administration, and use of drugs.

5. Certain Industrial Devices

a. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under this Section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

b. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under Subparagraph a of this Paragraph, shall apply for a license under 10 CFR 32.30 aid for a certificate of registration in accordance with LAC 33:XV.361.

La. Admin. Code tit. 33, § XV-304

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), LR 24:2091 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 27:1226 (August 2001), amended by the Office of the Secretary, Legal Division, LR 38:2746 (November 2012), LR 40:283 (February 2014), LR 40:1339 (July 2014), LR 41:1277 (July 2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq., and 2104(B)1.